Oral Anticoagulant in Chronic Kidney Disease: Benefits and Harms

MedicalResearch.com Interview with:

Sunil Badve MBBS, MD, DNB, FRACP, PhD, FASN Senior Research Fellow, Renal & Metabolic Division Staff specialist nephrologist | St George Hospital University of New South Wales The George Institute for Global Health Australia

Dr. Badve

Sunil Badve MBBS, MD, DNB, FRACP, PhD, FASN
Senior Research Fellow, Renal & Metabolic Division
Staff specialist nephrologist | St George Hospital
University of New South Wales
The George Institute for Global Health
Australia

MedicalResearch.com: What is the background for this study?

Response: Despite the high prevalence of cardiovascular thrombotic events and venous thromboembolism (VTE) in chronic kidney disease (CKD), oral anticoagulant therapy is often underutilized in patients with advanced CKD and dialysis-dependent end-stage kidney disease (ESKD) due to uncertainty of benefit and potential bleeding complications. This comprehensive systematic review was performed to study the benefits and harms of oral anticoagulant therapy in patients with CKD.

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Updated Expert Consensus Statement on Platelet Function/Genetic Testing for Guiding P2Y12 Receptor-Inhibitor Treatment in PCI

MedicalResearch.com Interview with:

Prof. Dr. med. Dirk Sibbing, MHBA, FESC Oberarzt, Medizinische Klinik und Poliklinik I Ludwig-Maximilians-Universität (LMU) München Chairperson ESC Working Group on Thrombosis München, Germany

Prof. Sibbing

Prof. Dr. med. Dirk Sibbing, MHBA, FESC
Oberarzt, Medizinische Klinik und Poliklinik I
Ludwig-Maximilians-Universität (LMU) München
Chairperson ESC Working Group on Thrombosis
München, Germany 

MedicalResearch.com: What is the background for this consensus statement? What are the main findings that led to these conclusions?

Response: The availability of different P2Y12 receptor inhibitors (clopidogrel, prasugrel, ticagrelor) with varying levels of potency has enabled physicians to contemplate individualized treatment concepts. Such concepts may include escalation or de-escalation of P2Y12 inhibiting therapy.

Alternative DAPT strategies may be chosen according to the clinical setting (stable coronary artery disease vs. acute coronary syndrome), the stage of the disease (early vs. chronic treatment) and patient risk for ischemic and bleeding complications. As always in clinical medicine, guidance by means of biomarkers or risk scores is always helpful and warranted. Here specifically, a tailored DAPT approach may be potentially guided by platelet function (PFT) or genetic testing. Continue reading

Does Genetic Information Encourage Doctors to Switch Anticoagulation Medications?

MedicalResearch.com Interview with:

Thomas J. Povsic, MD, PhDInterventional CardiologistDuke Clinical Research InstituteDuke University School of MedicineDurham, North Carolina 

Dr. Povsic

Thomas J. Povsic, MD, PhD
Interventional Cardiologist
Duke Clinical Research Institute
Duke University School of Medicine
Durham, North Carolina 

MedicalResearch.com: What is the background for this study? 

Response: The background for this study is that it is unknown how mandatory reporting of CYP2C19 metabolizer status affects how doctors treat patients or to what degree provision of this information would affect choice of a P2Y12 inhibitor within a clinical trial.

As part of the GEMINI-ACS trial, all patients underwent CYP2C19 metabolizer testing.  This trial enrolled patients with a recent acute coronary syndrome and randomized them to aspirin or a low dose of rivaroxaban.  All patients were also to be treated with ticagrelor or clopidogrel, which was at the discretion of the investigator.  Investigators were given information regarding the CYP2C19 metabolizer status about a week after randomization.  Importantly prior to randomization, all investigators were asked how they expected to use this information, and then we followed what they actually did.

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Stroke: Thrombolysis Guided by Perfusion Imaging Extended Time Window up to 9 Hours after Onset

MedicalResearch.com Interview with:

Geoffrey A Donnan AOMBBS, MD, FRCP, FRACP, FAAHMSProfessor of NeurologyUniversity of Melbourne, Melbourne Brain Centre,Royal Melbourne and Austin Hospitals

Prof. Donnan

Geoffrey A Donnan AO
MBBS, MD, FRCP, FRACP, FAAHMS
Professor of Neurology
University of Melbourne, Melbourne Brain Centre
Royal Melbourne and Austin Hospital

MedicalResearch.com: What is the background for this study? What are the main findings? 

Response: Currently the thrombolysis time window for acute ischemic stroke is restricted to less than 4.5 hours from stroke onset and patients with wake-up stroke are not eligible.

EXTEND is a multi-centre randomised placebo-controlled trial involving patient with acute ischemic stroke who presented between 4.5 to 9 hours of stroke onset or with wake-up-stroke and had penumbral tissue demonstrated on automated perfusion imaging.

Patients were randomised to receive either alteplase or placebo. In total there were 225 patients recruited and the patients who received alteplase had higher rate of excellent functional outcome at 3 months (35.4% vs 29.5% adjusted odd ration 1.44 with 95% confidence interval 1.01 – 2.06 p=0.04). Patients who received alteplase achieved higher rate of early neurological improvement at day 3, reperfusion and recanalization at 24 hours. There was numerically more haemorrhage in the alteplase group but this not negate the functional benefit and there was no difference in the rate of mortality between the two groups.  Continue reading

Stroke: Experimental Antiplatelet Antibody Only Attacks Clots, Without Increasing Bleeding Risk

MedicalResearch.com Interview with:

MedicalResearch.com Interview with:Martine Jandrot-Perrus MD, PhD.Emeritus Research ProfessorInserm University Paris DiderotActicor BiotechHôpital BichatFrance

Dr. Jandrot-Perrus


Martine Jandrot-Perrus MD, PhD.
Emeritus Research Professor
Inserm University Paris Diderot
Acticor Biotech
Hôpital Bichat
France 

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Blood platelets are key actors in thrombosis a leading cause of global mortality estimated to account for 1 in 4 death worldwide in 2010.

Thrombosis is associated with cardiovascular diseases (myocardial infarction, stroke, lower limb ischemia, venous thromboembolism), and with numerous pathologies such as cancer, infections or inflammatory diseases. Currently available antiplatelet drugs are the cornerstone of therapy for patients with acute coronary syndromes. However, these drugs all carry an inherent risk of bleeding that restricts their use in sensitive populations and when arterial thrombosis occurs in the cerebral territory. At present the only acute treatment option available for ischemic stroke consists in revascularization by thrombolysis, and/or mechanical thrombectomy. But the number of patients eligible to these treatments is low (» 15% of all patients) and the success rate does not exceed 50%. The responsibility of platelets in the failure for thrombolysis / thrombectomy to restore vascular patency is strongly suspected.

There is thus a clear medical need for new antiplatelet drugs with an improved safety profile. We set out to develop ACT017, a novel, first in class, therapeutic antibody to platelet glycoprotein VI with potent and selective antiplatelet effects. The interest of GPVI resides in the fact that it’s a receptor involved in the development of occlusive thrombi but that it is not strictly required for physiological hemostasis.
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Does Intermittent Leg Compression Reduce Blood Clots or Pulmonary Embolism?

MedicalResearch.com Interview with:

Yaseen M. Arabi, M.DIntensive Care DepartmentMinistry of National Guard Health AffairsICU 1425, Riyadh, Saudi Arabia

Dr. Arabi

Yaseen M. Arabi, M.D
Intensive Care Department
Ministry of National Guard Health Affairs
Riyadh, Saudi Arabia 

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Venous thromboembolism, including deep vein thrombosis and pulmonary embolism, is a complication of critical illness. Studies have demonstrated that despite pharmacologic thromboprophylaxis with unfractionated heparin or low-molecular weight heparin, 5-20% of critically ill patients develop deep vein thrombosis (DVT). The PREVENT trial evaluated whether adjunctive intermittent pneumatic compression reduces incident proximal lower limb DVT as detected on twice-weekly lower limb ultrasonography in critically ill patients receiving pharmacologic thromboprophylaxis with unfractionated heparin or low-molecular-weight heparin.

The trial was conducted in 20 sites in Saudi Arabia, Canada, Australia and India and included 2003 patients.

The trial found no difference in the primary end point of proximal leg DVT. The addition of intermittent pneumatic compression to pharmacologic thromboprophylaxis did not result in a lower incidence of pulmonary embolism or a composite outcome of venous thromboembolism or death from any cause at 28 days when compared to pharmacologic thromboprophylaxis alone.

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Atrial Fibrillation: Antithrombotic Therapy after Acute Coronary Syndrome or PCI

MedicalResearch.com Interview with:

Renato D. Lopes MD, MHS, PhD Duke University Medical Center Duke Clinical Research Institute Durham, NC 27705

Dr. Renato Lopes

Renato D. Lopes MD, MHS, PhD
Professor of Medicine
Division of Cardiology
Duke University Medical Center
Duke Clinical Research Institute

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: In patients with acute coronary syndromes (ACS), approximately 20% to 30% of those with nonvalvular atrial fibrillation (NVAF) have concomitant coronary artery disease (CAD), and 5 to 10% of patients who undergo PCI have NVAF. These patients often receive both antiplatelet therapy and oral anticoagulants; and how best to combine these agents to minimize bleeding risk without compromising protection against thrombosis is an important unanswered question.

Analysis of results for bleeding indicated no significant interaction between the two randomization factors permitting independent analysis of results for the two key comparisons. The first showed that apixaban was both non-inferior and significantly superior to VKA for the primary outcome with a 31% reduction in the relative risk for bleeding. Aspirin significantly increased the relative risk for bleeding versus placebo by 89%.

Results for the composite of death and hospitalization showed that apixaban resulted in a relative risk reduction of 17%, primarily driven by a reduction in all cause hospitalization. There was no significant difference between results for aspirin versus placebo for this outcome.

Analysis of the composite of death and ischemic events indicated no significant differences in results for apixaban versus VKA or aspirin versus placebo.

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Home Treatment of Patients with Low-Risk Pulmonary Embolism

MedicalResearch.com Interview with:
Stavros V. Konstantinides, MD, PhD, FESC, FRCP(Glasg)

Professor, Clinical Trials, and Medical Director
Center for Thrombosis and Hemostasis (CTH)
Johannes Gutenberg University Mainz
Mainz, Germany

Stavros V. Konstantinides, MD, PhD, FESC, FRCP(Glasg)Professor, Clinical Trials, and Medical DirectorCenter for Thrombosis and Hemostasis (CTH)Johannes Gutenberg University MainzMainz, Germany

Dr. Konstantinides

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Acute pulmonary embolism (PE) is the third most frequent acute cardiovascular syndrome. It encompasses a wide spectrum of clinical symptoms and severity, ranging from massive, immediately life-threatening PE with hemodynamic collapse to the low-risk, stable patient with very few symptoms. These latter patients with acute low-risk PE may qualify for early discharge from hospital (e.g., within 48 hours) and continuation of treatment at home. This is a very promising strategy, because it may not only increase patient satisfaction and quality of life, but also help to reduce hospital-related complications and costs. However, it needed to be clearly determined, and tested in a prospective management trial, who are the appropriate candidates for an effective and safe home treatment approach. To this date, trials suggesting favorable clinical outcomes with home treatment of PE are small and date back to the era of vitamin K antagonists. Direct oral anticoagulants permitting a single drug treatment of PE are more promising in this regard, as they may make an early transition from hospital to ambulatory care both safer and more convenient.

The international Home Treatment of Pulmonary Embolism (HoT-PE) phase 4 management trial tested the efficacy and safety of early discharge and ambulatory anticoagulation treatment with the direct factor Xa inhibitor rivaroxaban in patients with acute low-risk PE. Patients were identified on the basis of

  • clinical criteria or PE severity, comorbidity, and contraindications; and
  • the absence of right heart failure or intracardiac thrombi on cardiac imaging. Early termination of the study was possible following the prespecified interim analysis, which was performed after recruitment and 3-month evaluation of 525 patients (50% of the planned trial population). At the interim analysis, the primary efficacy outcome of symptomatic recurrent venous thromboembolism or PE-related death occurred in only 3 (0.6%) patients (compared to an estimated 1.7% rate based on historical data). This rate was sufficiently low to reject the primary hypothesis as predefined in the statistical analysis plan. None of the recurrent events was nonfatal.Major bleeding occurred in 6 (1.2%) patients of the safety population. The study could therefore be terminated early for efficacy. 

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Many Patients Taking Warfarin Plus Aspirin Without Clear Indication

MedicalResearch.com Interview with:

Geoffrey Barnes, MD, MScAssistant ProfessorVascular and Cardiovascular MedicineUniversity of Michigan

Dr. Barnes

Geoffrey Barnes, MD, MSc
Assistant Professor
Vascular and Cardiovascular Medicine
University of Michigan

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Both aspirin and warfarin are commonly used medications meant to prevent thrombotic complications, but might increase rates of bleeding complications.

We used a multi-center anticoagulation collaborative to explore how often patients being treated with warfarin were also taking aspirin but without a clear indication. We found that more than one-third (37.5%) of warfarin-treated patients without a clear reason for aspirin therapy were receiving aspirin. And these patients on both warfarin and aspirin experienced higher rates of bleeding and emergency department visits for bleeding than the patients taking warfarin alone. There were no differences in the rate of thrombotic events between the patients taking warfarin alone or those taking warfarin plus aspirin.  Continue reading

Equation Predicts Bleeding Risk of Aspirin for Prevention of Cardiovascular Disease

MedicalResearch.com Interview with:

Dr Vanessa Selak, MBChB, MPH, PhD, FAFPHM, FNZCPHMSenior Lecturer, Section of Epidemiology & BiostatisticsSchool of Population Health, Faculty of Medical and Health SciencesUniversity of Auckland

Dr. Selak

Dr Vanessa Selak, MBChB, MPH, PhD, FAFPHM, FNZCPHM
Senior Lecturer, Section of Epidemiology & Biostatistics
School of Population Health
Faculty of Medical and Health Sciences
University of Auckland

MedicalResearch.com: What is the background for this study?

Response: In order to determine the balance of benefits and harms of aspirin in primary prevention there’s a need to know an individual’s risk of CVD and their risk of a major bleed without aspirin.

We have lots of equations that can be used to determine, among people considering aspirin for primary prevention, an individual’s risk of CVD, but few bleeding risk equations that can be used to determine their risk of a major bleed.

We sought to develop a bleeding risk equation that can be used to determine the risk of a major bleed among people in whom aspirin is being considered for the primary prevention of CVD. Continue reading

Blood Clots Linked to Oral Hormone Replacement for Menopause Symptoms

MedicalResearch.com Interview with:

Yana Vinogradova, PhD Research Fellow Department of Primary Care School of Medicine University of Nottingham University Park, Nottingham

Dr. Vinogradova

Yana Vinogradova, PhD
Research Fellow
Department of Primary Care
School of Medicine
University of Nottingham
University Park, Nottingham

MedicalResearch.com: What is the background for this study?  

Response: The study targeted middle age women going through menopause.  This is the stage of life when women naturally reach the end of their reproductive life and their hormones gradually decrease.  Some women experience unpleasant effects such as hot flushes, night sweats, mood swings, memory and concentration loss, headaches.  Quality of life may be severely affected.  Hormone replacement therapy uses a class of drugs, which, like all drugs, have side effects.   VTE is a serious side effect which can have a lethal outcome.

There are different preparations of hormones available for such women.  Some of them were extensively studied in a large American Trial Women’s Health Initiative and showed the risk of VTE to be twice as high for women who took them.  However, these well-studied drugs are mostly prescribed in America.  The more popular drugs in Europe and the UK have been much less studied, so it was unclear how they compared.  Continue reading

XARELTO® Associated With a Decreased Risk of Recurrent VTE

MedicalResearch.com Interview with:

Paul Burton MD, PhD, FACC Vice President, Medical Affairs Internal Medicine Janssen Scientific Affairs, LLC.

Dr. Burton

Paul Burton MD, PhD, FACC
Vice President, Medical Affairs
Internal Medicine
Janssen Scientific Affairs, LLC.

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: More than 900,000 Americans experience a venous thromboembolism (VTE) each year, with about one-third of these occurrences being fatal. Once a person experiences a VTE, they are at increased risk of a repeat occurrence. Guidelines currently recommend standard anticoagulant therapy with a Factor Xa inhibitor, like XARELTO® (rivaroxaban), for three months or longer. For those people who have had a VTE and stop anticoagulant therapy, as many as 10 percent of them will experience another VTE within one year and 20 percent within three years.

This study examined extended use of XARELTO® after the recommended three-month treatment period in patients who experienced an initial VTE, showing XARELTO® was associated with a decreased risk of recurrent VTE with no increase in major bleeding during this time period.  Continue reading

Healthcare Costs in Patients with Cancer Rise with Increasing Risk of Venous Thromboembolism

MedicalResearch.com Interview with:

Paul Burton MD, PhD, FACC Vice President, Medical Affairs Internal Medicine Janssen Scientific Affairs, LLC.

Dr. Burton

Paul Burton MD, PhD, FACC
Vice President, Medical Affairs
Internal Medicine
Janssen Scientific Affairs, LLC.

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Despite being largely preventable, venous thromboembolism (VTE) is the second leading cause of death in people with cancer. The risk of VTE is five times greater in people with cancer than those without cancer, and that risk is magnified in those receiving certain types of chemotherapy, in the newly diagnosed and in those with more advanced, metastatic disease. This 6,194-patient study examined economic burden associated with VTE, and found patients newly diagnosed with cancer who are at a higher risk of a VTE had significantly higher all-cause and VTE-related health care costs compared to patients with a lower risk of VTE. Continue reading

Lower Overall Costs with Rivaroxaban (XARELTO® ) vs Warfarin Among Morbidly Obese Patients with Venous Thromboembolism

MedicalResearch.com Interview with:

Paul Burton MD, PhD, FACC Vice President, Medical Affairs Internal Medicine Janssen Scientific Affairs, LLC.

Dr. Burton

Paul Burton MD, PhD, FACC
Vice President, Medical Affairs
Internal Medicine
Janssen Scientific Affairs, LLC.

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Treatment of venous thromboembolism (VTE) is complicated among morbidly obese patients. Current guidelines do not recommend use of Factor Xa inhibitors in these patients due to limited clinical data available. That’s why Janssen undertook this study to examine XARELTO® (rivaroxaban) in these patients. In this 5,780-patient retrospective study, results found patients treated with XARELTO® had a similar risk of recurrent VTE and major bleeding compared to those taking warfarin.

However, treatment with XARELTO® was associated with less all-cause health care resource utilization (HCRU) (e.g., inpatient hospitalizations and outpatient visits) and reduced total medical costs compared to warfarin. Of note, patients taking XARELTO® had an average $2,829 lower total medical costs per patient per year (PPPY) than those taking warfarin, which was mainly driven by lower hospitalization costs. Continue reading

Electronic Decision Support Facilitates Home Discharge of Some PE Patients From ER

Dr-David R Vinson

Dr. Vinson

MedicalResearch.com Interview with:
David R. Vinson, MD
Department of Emergency Medicine
Kaiser Permanente Sacramento Medical Center Sacramento, CA

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: At least one-third of emergency department (ED) patients with acute blood clots in the lung, or pulmonary embolism (PE), are eligible for expedited discharged to home, either directly from the ED or after a short (<24 hour) period of observation. Yet in in most hospitals in the U.S. and around the world nearly all ED patients with acute PE are hospitalized. These unnecessary hospitalizations are a poor use of health care resources, tie up inpatient beds, and expose patients to the cost, inconvenience, and risk of inpatient care. The better-performing medical centers have two characteristics in common: they help their physicians identify which PE patients are candidates for outpatient care and they facilitate timely post-discharge follow-up. At Kaiser Permanente Northern California (KPNC), we have had the follow-up system in place for some time, but didn’t have a way to help our physicians sort out which patients with acute PE would benefit from home management.

To correct this, we designed a secure, web-based clinical decision support system that was integrated with the electronic health record. When activated, it presented to the emergency physician the validated PE Severity Index, which uses patient demographics, vital signs, examination findings, and past medical history to classify patients into different risk strata, correlated with eligibility for home care. To make use of the PE Severity Index easier and more streamlined for the physician, the tool drew in information from the patient’s comprehensive medical records to accurately auto-populate the PE Severity Index. The tool then calculated for the physician the patient’s risk score and estimated 30-day mortality, and also offered a site-of-care recommendation, for example, “outpatient management is often possible.” The tool also reminded the physician of relative contraindications to outpatient management. At the time, only 10 EDs in KPNC had an on-site physician researcher, who for this study served as physician educator, study promotor, and enrollment auditor to provide physician-specific feedback. These 10 EDs functioned as the intervention sites, while the other 11 EDs within KPNC served as concurrent controls. Our primary outcome was the percentage of eligible ED patients with acute PE who had an expedited discharge to home, as defined above.

During the 16-month study period (8-month pre-intervention and 8-months post-intervention), we cared for 1,703 eligible ED patients with acute PE. Adjusted home discharge increased at intervention sites from 17% to 28%, a greater than 60% relative increase. There were no changes in home discharge observed at the control sites (about 15% throughout the 16-month study). The increase in home discharge was not associated with an increase in short-term return visits or major complications.  Continue reading

NEJM: Rivaroxaban (XARELTO®) For Thromboembolism Prevention after Medical Illness

MedicalResearch.com Interview with:

Alex C Spyropoulos, MD, FACP, FCCP, FRCPC Professor of Medicine – The Donald and Barbara Zucker School of Medicine at Hofstra/Northwell Professor - The Center for Health Innovations and Outcomes Research - The Feinstein Institute for Medical Research System Director – Anticoagulation and Clinical Thrombosis Services Northwell Health at Lenox Hill Hospital New York, NY 10075

Dr. Spyropoulos

Alex C Spyropoulos, MD, FACP, FCCP, FRCPC
Professor of Medicine – The Donald and Barbara Zucker School of Medicine at Hofstra/Northwell
Professor – The Center for Health Innovations and Outcomes Research – The Feinstein Institute for Medical Research
System Director – Anticoagulation and Clinical Thrombosis Services
Northwell Health at Lenox Hill Hospital
New York, NY 10075

MedicalResearch.com: What is the background for this study?

Response: Hospitalised medically ill patients have a significant risk of developing venous thromboembolism (VTE) within 6 weeks after discharge. The role of extended thromboprophylaxis in this population with either low molecular weight heparin or the direct oral anticoagulants remains uncertain, as it has shown either excess bleeding or beneficial effects mainly from reducing asymptomatic deep vein thrombosis (DVT).

The MARINER trial was designed to compare rivaroxaban with placebo for the prevention of the composite outcome of symptomatic VTE and VTE-related death in medically ill patients at increased risk of VTE post-hospital discharge. The principal safety objective was major bleeding.

The trial was a randomized, double-blind, placebo-controlled, event-driven study that included a total of 12,024 patients aged ≥40 years who had been hospitalised with an acute medical illness for 3-10 consecutive days and had additional VTE risk factors as defined by the modified IMPROVE VTE risk score of ≥4 or a score of 2 or 3 plus a plasma D-dimer level more than twice the upper limit of normal). The rivaroxaban regimen consisted of 10 mg once daily in patients with a creatinine clearance (CrCl) of >=50ml/min or 7.5 mg for patients with a CrCl of 30 to <50 ml/min. The first dose was given on the day of discharge and the last dose at Day 45. Patients were followed up for an additional 30 days. Baseline characteristics were well matched between groups and typical of a medically ill population.

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Outbreak of Synthetic Cannabinoid–Associated Bleeding Disorders in Illinois

MedicalResearch.com Interview with:

Dr. Amar Kelkar MD Clinical Fellow Division of Hematology & Oncology, Department of Medicine University of Florida College of Medicine, UF Health Shands Hospital

Dr. Kelkar

Dr. Amar Kelkar MD
Clinical Fellow
Division of Hematology & Oncology, Department of Medicine
University of Florida College of Medicine, UF Health Shands Hospital

MedicalResearch.com: What is the background for this study? What are synthetic cannabinoids?

Response: Starting in March 2018, patients began reporting to hospitals and clinics with unexplained and prolonged bleeding symptoms, first in Chicago, Illinois, and then spreading to Peoria, Illinois and elsewhere. This gained a lot of press because the initial identifying factor was that all the patients had reported recent use of synthetic cannabinoids. As the matter was studied further, it was determined that these patients were likely exposed to an anticoagulant poison mixed in with the synthetic cannabinoids.

Synthetic cannabinoids are lab-derived illicit drugs that target the cannabinoid receptors that are also targeted by marijuana. They go by many names including synthetic marijuana, K2, and Spice.

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Some Pulmonary Embolism Patients Can Be Treated at Home

MedicalResearch.com Interview with:

Joseph Bledsoe MD, FACEP Clinical Assistant Professor of Emergency Medicine Stanford Medicine Director of Research Department of Emergency Medicine Intermountain Medical Center Murray, UT 84157

Dr. Bledsoe

Joseph Bledsoe MD, FACEP
Clinical Assistant Professor of Emergency Medicine
Stanford Medicine
Director of Research
Department of Emergency Medicine
Intermountain Medical Center
Murray, UT 84157

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Patients with blood clots in the lungs (pulmonary embolism) (PE) are routinely admitted to the hospital for blood thinning medications in the United States. However, evidence from other countries has shown that with appropriate risk stratification patients may be safe for outpatient treatment for their PE.

Our study is the largest prospective management study in the US to evaluate home treatment of patients with acute pulmonary embolism. We enrolled 200 patients and after risk stratification with the PE severity index score, leg ultrasounds and echocardiograms performed in the emergency department, patients were treated with blood thinning medications at home with routine outpatient follow up.

During the 90 day follow up period we found only one patient suffered a bleeding event after a traumatic injury, without any cases of recurrent symptomatic blood clots or death.  Continue reading

Intracranial Hemorrhage Risk with NOACs vs Aspirin

MedicalResearch.com Interview with:
medical researchDr. Michael Lee
Department of Neurology
Chang Gung University College of Medicine
Chang Gung Memorial Hospital Taiwan

MedicalResearch.com: What is the background for this study?

Response: Although NOACs and aspirin are in general protective in different vascular beds, NOACs might be an attractive choice for stroke prevention in certain clinical situations, such as in people without recognized atrial fibrillation, but with an embolic stroke of undetermined source or atrial cardiopathy because of their propensity to also cause stroke through cardiac emboli.

Nonetheless, the benefit of NOACs over aspirin for stroke protection is likely to be less promising in people without atrial fibrillation, as compared to people with atrial fibrillation. Therefore it is even more important to clarify whether individual NOACs with of various doses harbor comparable risks of intracranial hemorrhage with aspirin based on the evidence currently available.

MedicalResearch.com: What are the main findings? 

Response: Rivaroxaban 15-20mg once daily substantially increased the risks of intracranial hemorrhage while rivaroxaban 10mg daily and apixaban 5mg twice daily were not. 

MedicalResearch.com: What should readers take away from your report?

Response: Rivaroxaban 15-20mg once daily possessed substantial higher risks of intracranial hemorrhage than aspirin, its use in people without atrial fibrillation could not be encouraged.  

MedicalResearch.com: What recommendations do you have for future research as a result of this work? 

Response: It may be worthwhile to conduct randomized controlled trials comparing certain NOAC (e.g. apixaban 5mg twice daily) and aspirin in patients without atrial fibrillation, but with potential sources of cardiac emboli that can cause stroke.

No disclosures 

Citation:

Huang W, Singer DE, Wu Y, et al. Association of Intracranial Hemorrhage Risk With Non–Vitamin K Antagonist Oral Anticoagulant Use vs Aspirin UseA Systematic Review and Meta-AnalysisJAMA Neurol. Published online August 13, 2018. doi:10.1001/jamaneurol.2018.2215

 

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More Data Needed To Justify Risks and Costs of IVC Filters

MedicalResearch.com Interview with:

David L. Brown, MD, FACC Professor of Medicine Cardiovascular Division Washington University School of Medicine St. Louis, MO 63110

Dr. Brown

David L. Brown, MD, FACC
Professor of Medicine
Cardiovascular Division
Washington University School of Medicine
St. Louis, MO 63110

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: There is very little high quality data for use of IVC filters in general and no high quality data for using them in the population of patients who have had a DVT or PE and have a contraindication to anticoagulation.

However, this is the patient population for which filters are most commonly placed. Using administrative, observational data, we found that IVC filter placement in this all-comer population was associated with an increased risk of 30-day mortality after adjusting for baseline differences and immortal time bias. Continue reading

Cardiovascular Risks of Hormone Therapy in Transgender Individuals

MedicalResearch.com Interview with:

Michael Goodman, MD, MPH Professor of Epidemiology Director, MD/MPH program Emory University School of Public Health Atlanta, GA  30322

Dr. Goodman

Michael Goodman, MD, MPH
Professor of Epidemiology
Director, MD/MPH program
Emory University School of Public Health
Atlanta, GA  30322

MedicalResearch.com: What is the background for this study? What are the main findings? 

Response: There is a concern that hormone therapy may be associated with higher risk of certain cardiovascular problems such as heart attacks, stroke and formation of blood clots (“venous thromboembolism”).

To study this concern we examined data on 4,960 transgender and gender non-conforming people enrolled in Kaiser Permanente health systems in Georgia, Northern California, and Southern California. They were matched to 48,686 cisgender men and 48,775 cisgender women.  Below are the main findings

  • Rates of venous thromboembolism in all transwomen were approximately twice as high as the rates among cisgender men or cisgender women. The data for stroke and myocardial infarction demonstrated little difference between transwomen and cisgender men, but 80% to 90% higher rates among transwomen compared to cisgender women.
  • When the analyses focused specifically on transwomen who started therapy with female hormone estrogen at Kaiser Permanente, the incidence of both venous thromboembolism and stroke was more clearly elevated relative to either reference group.  There was evidence that incidence of both of these conditions among transwomen was particularly increased two to six years after estrogen initiation. By contrast, the association between estrogen therapy and myocardial infarction was less evident due to relatively few observed events.
  • Transmen did not appear to have significantly higher rates of venous thromboembolism, ischemic stroke, or myocardial infarction than their non-transgender counterparts, but this group was rather young and included a relatively small proportion of participants who initiated their hormone therapy during the study.

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Study Finds Direct Oral AntiCoagulants (DOACs) Safe in A Fib

MedicalResearch.com Interview with:

Yana Vinogradova, PhD, Research Fellow Division of Primary Care, School of Medicine University of Nottingham Nottingham

Dr. Vinogradova

Yana Vinogradova, PhD, Research Fellow
Division of Primary Care, School of Medicine
University of Nottingham
Nottingham

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Anticoagulants are prescribed for treatment and prevention of thrombosis and stroke but may lead to major bleeding.  Unlike the older drug warfarin, newer direct oral anticoagulants do not require regular blood tests but their safety was shown only in selected patients and in trial conditions.

The study found that Direct Oral AntiCoagulants (DOACs) are safer than warfarin in terms of bleeding risks with apixaban being the safest. 

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Venous Thromboembolism Prophylaxis Over & Underutilized in Some Hospitalized Patients

MedicalResearch.com Interview with:
Paul Grant, MD

Associate Professor of Medicine Associate Chief Medical Information Officer Director, Perioperative and Consultative Medicine Division of Hospital Medicine Department of Internal Medicine Michigan Medicine University of Michigan

Dr. Grant

Associate Professor of Medicine
Associate Chief Medical Information Officer
Director, Perioperative and Consultative Medicine
Division of Hospital Medicine
Department of Internal Medicine
Michigan Medicine
University of Michigan

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: It is well known that hospitalized medical patients are at risk for venous thromboembolism VTE, but the severity of patient risk can vary significantly. National guidelines have consistently stated that low-risk patients should not receive VTE prophylaxis beyond early ambulation.

In this retrospective cohort study, we analyzed data from 52 hospitals participating in the Michigan Hospital Medicine Safety consortium. Trained medical record abstractors at each hospital collected data from 44,775 medical patients including VTE risk factors, type of VTE prophylaxis administered, and contraindications to pharmacologic prophylaxis. Individual patient risk of VTE was determined using the Padua risk assessment model.

Of the 32,549 low-risk patients, 77.9% received excess venous thromboembolism prophylaxis as either pharmacologic prophylaxis (30.6%), mechanical prophylaxis (20.8%), or both (26.5%). In the 12,226 high-risk patients, VTE prophylaxis was underused in 22% of patients. The rates of inappropriate prophylaxis varied considerably by hospital.  Continue reading

Risk of Cancer Triples Following Blood Clot in Leg

MedicalResearch.com Interview with:
Dr. Jens Sundbøll
Department of Clinical Epidemiology
Aarhus University Hospital
Aarhus, Denmark

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: The incidence of acute peripheral arterial occlusion is approximately 1.5 cases per 10,000 person-years. In comparison, the incidence rate of deep venous thrombosis is about 5-10cases per 10,000 person-years. It has been established previously that deep venous thrombosis in the lower limb and pulmonary embolism may be presenting symptoms of cancer and is associated with a poor cancer prognosis. However, whether arterial thromboembolism of the lower limb also can represent prodromal symptoms of occult cancer and worsen cancer prognosis has never been investigated.

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Varicose Veins Associated With Increased Risk of Deep Vein Blood Clots

MedicalResearch.com Interview with:

Shyueluen Chang

Shyueluen Chang

Shyueluen Chang MD
Phlebologist with Dermatologist background
Vein Clinic, Department of Dermatology,
Chang Gung Memorial Hospital
Taoyuan, Taiwan

MedicalResearch.com: What is the background for this study?  

Response: Varicose veins are common, with about 23 percent of U.S. adults having the condition, but they are rarely thought to be associated with serious health risks.

In contrast, venous thrombosis (DVT), pulmonary embolism (PE), and peripheral artery disease (PAD) are also vascular diseases that are associated with serious systemic effects. Not much is known about varicose veins and the risk of other vascular diseases. Elucidating potential associations between varicose veins and health-threatening diseases is important.

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Aspirin or Rivaroxaban for VTE Prophylaxis after Hip or Knee Arthroplasty?

MedicalResearch.com Interview with:

Dr. David R. Anderson, MD, FRCPC, FACP Faculty of Medicine Dean, Professor Dean, Faculty of Medicine Division of Hematology, Department of Medicine  & Nova Scotia Health Authority

Dr. Anderson

Dr. David R. Anderson, MD, FRCPC, FACP
Faculty of Medicine Dean, Professor
Dean, Faculty of Medicine
Division of Hematology, Department of Medicine
& Nova Scotia Health Authority

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Blood clots in the lungs (pulmonary embolism) and veins of the legs (deep vein thrombosis) are well recognized complications following total hip and knee arthroplasty surgeries.  Prior to the routine use of antithrombotic prophylaxis, pulmonary embolism was the most common cause of death following these procedures.  Oral anticoagulants such as rivaroxaban are commonly prescribed for the indication of preventing blood clots following total hip or knee arthroplasty.  For maximal benefit these agents are continued following surgery for up to five weeks following total hip arthroplasty and for two weeks following total knee arthroplasty.

There is evidence that aspirin has some benefit for the prevention of deep vein thrombosis and pulmonary embolism following total hip or knee arthroplasty.  However there is less evidence for its benefit than for oral anticoagulants.  We reasoned that aspirin would potentially be an attractive alternative for extended out of hospital prophylaxis following total hip or knee arthroplasty for patients who received a short course (5 days )of rivaroxaban following surgery.  Aspirin would be attractive for this indication because of its low cost, ease of use, and low rates of side effects.

Our study demonstrated that in a randomized controlled trial involving a large group (over 3400) of patients undergoing total hip or knee arthroplasty that extended therapy with aspirin was comparable to rivaroxaban for the prevention of deep vein thrombosis and pulmonary embolism following surgery.  Low rates of complications (< 1%) were observed with both treatment arms.  We also found that rates of clinically important bleeding complications (the most common side effect with antithrombotic drugs) were uncommon and similar with the two agents.

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Standard or Low Dose Alteplase in Acute Ischemic Stroke–Does It Matter?

MedicalResearch.com Interview with:

Craig Anderson | MD PhD FRACP Executive Director  Professor of Neurology and Epidemiology, Faculty of Medicine, UNSW Sydney Neurologist, Neurology Department, Royal Prince Alfred Hospital The George Institute for Global Health at Peking University Health Science Center Haidian District | Beijing, 100088 P.R. China

Prof. Anderson

Craig Anderson | MD PhD FRACP
Executive Director
Professor of Neurology and Epidemiology, Faculty of Medicine, UNSW Sydney
Neurologist, Neurology Department, Royal Prince Alfred Hospital
The George Institute for Global Health at Peking University Health Science Center
Haidian District | Beijing, 100088 P.R. China

MedicalResearch.com: What is the background for this study? What are the main findings?

Response:  There is much controversy over the benefits of a lower dose of intravenous alteplase, particularly in Asia, after the Japanese regulatory authorities approved a dose of 0.6 mg/kg 10 years ago compared to the US FDA and other regulatory authorities approving 0.9 mg/kg 20 years ago.  The investigator inititiated and conducted ENCHANTED trial aimed to determine the effectiveness and safety of these two doses in an international multicentre pragmatic open design.

The main results did not confirm the low-dose to be statistically ‘non-inferior’ partly due to the primary outcome measure chosen and partly due to the statistical approach, but it did confirm that the lower dose was safer with less risk of the major complication of this treatment, that of major bleeding in the brain.  However, it would appear that this safety effect was offset by some reduce efficacy in terms of functional recovery.

The aim of this secondary analysis of the trial data was to examine in more detail the differences between low and standard dose alteplase according to the participants’ age, ethnicity (Asian vs non-Asian) and severity of neurological deficit at the time of treatment.  We did this because the popular belief is that a lower dose might be preferred in older people, and Asians, because of the potential for more likelihood of bleeding, and preferentially to use the standard dose in those with more severe strokes potentially due to greater ‘clot burden’ from a blocked artery to the brain.

The results showed that the main findings on the outcome of surviving free of disability were the same according to age, ethnicity and stroke severity – that is, there was no preferential dose in any of these groups.  Similarly, the safety benefit of low dose alteplase on brain haemorrhage, did not clearly translate into clinical disability outcomes in any of the patient groups studied.

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Genetic Testing Reduces Risk Of Side Effects From Anticoagulation After Surgery

MedicalResearch.com Interview with:

Anne R. Bass, MD Associate Professor of Clinical Medicine Weill Cornell Medical College Rheumatology Fellowship Program Director Hospital for Special Surgery New York, NY 10021

Dr. Bass

Anne R. Bass, MD
Associate Professor of Clinical Medicine
Weill Cornell Medical College
Rheumatology Fellowship Program Director
Hospital for Special Surgery
New York, NY 10021

MedicalResearch.com: What is the background for this study?

Response: Blood thinners are used after orthopedic surgery to prevent blood clots from forming in the legs and traveling to the lungs. They are also used in patients with certain heart diseases to prevent strokes. Blood thinners, like warfarin, are effective but can be associated with serious bleeding complications, especially if the wrong dose is given. Genetic testing can help doctors predict the right warfarin dose to use in an individual patient.

In this trial, ≈1600 elderly patients undergoing hip or knee replacement were randomly assigned to receive warfarin dosing based on genetics plus clinical factors (like height, weight and gender), or based on clinical factors alone. The specific genes tested wereVKORC1, CYP2C9, and CYP4F2 which influence warfarin metabolism and the body’s ability to produce clotting factors.

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Phase 3 Study Finds XARELTO® Superior to Aspirin for Long-Term Prevention of Recurrent Blood Clots in VTE

MedicalResearch.com Interview with:

Paul Burton, MD, PhD, FACC Vice President, Medical Affairs Janssen

Dr. Paul Burton

Paul Burton, MD, PhD, FACC
Vice President, Medical Affairs
Janssen

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Venous thromboembolism (VTE), which includes deep vein thrombosis (DVT) and pulmonary embolism (PE), affects more than 900,000 Americans each year; one-third of these occurrences are fatal. Once a person experiences a VTE, they are at risk of having another occurrence. Guidelines currently recommend anticoagulant therapy with a non-vitamin K antagonist oral anticoagulant (NOAC), like XARELTO® (rivaroxaban), for three months or longer. Once anticoagulant therapy is stopped, up to 10 percent of people will experience a recurrence during the first year and up to 20 percent within three years. In people who decide to stop anticoagulant therapy, guidelines currently suggest using aspirin for long-term prevention of recurrent VTE rather than no aspirin at all.

The Phase 3 EINSTEIN CHOICE study was designed to compare the efficacy and safety of XARELTO® to aspirin for continued VTE management in people who experienced an initial VTE. The study met its primary endpoint, finding both XARELTO® doses (10 mg or 20 mg once daily) to be superior to aspirin 100 mg once daily in preventing recurrent VTE, with no significant impact on safety. Specifically, XARELTO® 10 mg reduced the risk of recurrent VTE by 74 percent and XARELTO® 20 mg by 66 percent. Rates of major bleeding were comparable and low across all treatment groups.

These results were presented at the American College of Cardiology’s 64th Annual Scientific Session (ACC.17) during a Joint ACC/Journal of American Medical Association Late-Breaking Clinical Trials session and published simultaneously in The New England Journal of Medicine.

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Computerized Clinical Decision Support Systems Can Reduce Rate of Venous Thromboembolism

MedicalResearch.com Interview with:
Zachary Borabm, Research fellow

Hansjörg Wyss Department of Plastic Surgery
NYU Langone Medical Center

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Recent studies have shown that health care providers perform poorly in risk stratifying their patients for venous thromboembolism (VTE) which leads to inadequate VTE prophylaxis delivery, especially in surgical patients. Computerized Clinical Decision Support Systems (CCDSSs) are programs integrated into an electronic health record that have the power to aid health care providers. Using a meta-analysis study technique we were able to pool data from 11 studies, including 156,366 patients that either had CCDSSs intervention or routine care without CCDSSs.

Our main outcome measures were the rate of prophylaxis for VTE and the rate of actual VTE events. We found that CCDSSs increased the rate of VTE prophylaxis (odds ratio 2.35, p<0.001) and decreased the risk of VTE events (risk ratio 0.78, p<0.001).

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